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Viewpoints: Forum on IRBs

Negotiating Institutional Review Boards

Linda Shopes, March 2007

Editor's Note: This essay, along with two by E. Taylor Atkins and Zachary M. Schrag, as well as a bibliography by Linda Shopes, present different viewpoints on the contentious question of the role institutional review boards play or should play in relation to oral history. This first essay, based on (and updated from) a presentation the author made at an August 5, 2005, workshop sponsored by the American Historical Association on the education of historians, provides an overview of the problem and also explains various steps that have been taken and can be taken in the future to sustain oral historical research.

Two questions arise when embarking on any discussion of Institutional Review Boards and their relationship to oral history: Where does the directive for IRB review of research protocols come from? And why is it being applied to oral history?

The answer to the first question is the federal government, and more specifically Part 46 (Protection of Human Subjects) of Title 45 (Public Welfare) of the Code of Federal Regulations, commonly referred to as the Common Rule. The result of lengthy deliberations within both policy and professional circles, 45 CFR 46 was first promulgated in 1981 and, in its present form, in 1991. It was provoked in part by outrage at the violation of human rights present in certain medical experiments, including Nazi doctors' experiments on Holocaust victims and the Tuskegee Syphilis Study; it is intended to protect the rights, interests, and dignity of human research subjects—or research participants, as some prefer.1

Three ethical principles underlie 45 CFR 46, each codified in procedures to ensure adherence to the principle. These were first articulated in The Belmont Report, issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. These principles are:

a respect for persons as autonomous individuals capable of making decisions about their own behavior, or, in the case of individuals with "diminished autonomy," as needing specific protections, codified in 45 CFR 46 as procedures for securing informed consent from research subjects;

beneficence, or the obligation to minimize harm and maximize benefits to research subjects, codified as a directive to assess and balance risks and benefits of research;

and justice, or the equitable selection of research subjects, codified as terms for selection of subjects.2

While federal oversight of the Common Rule falls to Office of Human Research Protections (OHRP) within the Department of Health and Human Services, responsibility for implementing it falls to local, typically campus-based IRBs. IRBs are empowered by the regulations to approve or disapprove research protocols—or more typically, request their revision--based on their conformity to the principles and practices delineated by the regulations.

As to why these regulations are being applied to oral history, I note three reasons. First, early on, research in the behavioral and social sciences—though not specifically in history—was included within the regulatory embrace. The Common Rule defines human subjects research as "intervention and interaction with [a living] individual." Interviewing is clearly "interaction," which is further defined as "communication or interpersonal contact between investigator and subject" (46.102 [f]).

Reading 45 CFR 46 more carefully, however, it is clear that most oral history is, in fact, exempt from regulatory oversight. The regulations state that "research involving... interview procedures... [is exempt from this policy] unless (i) information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects [which is generally the case in oral history] and [this "and" is all important] (ii) disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, or reputation [which is not generally the case in oral history]" ( 46.101 [b] [2]). In other words, while most oral history narrators can be identified if in no other way than by their recorded voice, most do not reveal information that could, in the language of 45 CFR 46, "reasonably place [them] at risk."

However, the IRB—not the researcher—determines exemption, so we find ourselves in the position of submitting a description of our oral history research protocols to an IRB in order to apply for an exemption from IRB review of our research protocols. To be fair, applying for exemption can be less burdensome than IRB review; and exemption does free the researcher from further oversight.

The second reason for IRB review of oral history has to do with both institutional and federal policies. The Common Rule itself applies only to research funded by 17 federal agencies that subscribe to its terms. Notably, the National Endowment for the Humanities, which is the federal agency most likely to support research in history, is not among them. In fact, however, most universities and research centers that receive funding from any of these 17 agencies—and it would be hard to identify a one that does not—apply the terms of 45 CFR 46 to all research conducted within the institution, whether or not the research receives funding from one of these agencies, or is funded at all, for that matter. For it is in an institution's self-interest to apply the same oversight to all research conducted within the institution. The regulations themselves also require assurance that ethical safeguards are in place for all human subjects research conducted within an institution for that institution to be eligible for funds from any of the 17 agencies subscribing to the Common Rule. Most institutions simply choose to extend the Common Rule to all such research.

A third reason for the extension of IRB review to oral history interviewing is what some refer to as "mission creep." Universities are increasingly fearful of litigation or bad press over dangerous or controversial research. And they are equally aware that egregious violations of human subjects requirements have led to the suspension of all human subjects research within an institution. Although typically such concerns have focused on biomedical research, universities are increasingly subjecting other forms of research to tighter controls.3

What are the difficulties historians face when submitting protocols for oral history research to IRB review? Not surprisingly, given the ethical abuses that formed the context within which the Common Rule was developed, the regulations assume a scientific model of research. And if complaints received by the American Historical Association and the Oral History Association are any gauge, it is clear that IRB review of oral history is an awkward and at times contentious affair, as principles and procedures developed to protect human beings from potentially harmful scientific research are applied to more humanistic inquiry.4

The problems historians confront cluster in two areas: the potential an interview might have for inflicting psychological harm on the narrator and maintaining narrator privacy. Concern about psychological harm derives rather awkwardly from that section of the Common Rule that defines minimal risk as the "harm or discomfort ... encountered... during the performance of routine physical or psychological examinations or tests" (46.102 [i]), a formulation that simply has no relationship to historical research. The Guidebook issued by OHRP explicates the notion of psychological harm a bit, noting that "stress and feelings of guilt or embarrassment may arise simply from thinking or talking about one's own behavior or attitudes on sensitive topics."5 True enough, but given the open ended nature of an interview, one often doesn't know in advance if it will enter into a sensitive area: prior review by an IRB, or even interviewer intent, can't prevent this from happening, and one might argue that to prevent a narrator from discussing such subjects may be more harmful than listening to him or her. Furthermore, psychological harm is difficult to gauge: what might be construed as psychologically threatening for one person may not be for another.

More to the point, the assumption that harm can result from talking about sensitive topics is contradicted by both anecdotal and scientific evidence, which suggests that talking about even the most difficult of subjects is generally not perceived as harmful but indeed as having a salutary effect.6 And insofar as oral history narrators freely agree to be interviewed about past experiences, there is something patronizing about assuming they need to be protected from talking about those experiences, that they cannot decide which experiences, including traumatic experiences, they wish to talk about, which they do not.

To my knowledge, concerns about psychological harm have not prevented any oral history research from going forward, though they have led to adjustments in research protocols. What we don't know is how a zealous IRB might use concerns about psychological harm to constrain research on subjects like sexual identity or political activism or acts of bigotry. Nor do we know their potential for discouraging research on presumably sensitive topics, though again anecdotal evidence suggests that some students are unwilling to undertake such research out of concern about IRB interference and instead opt for safer topics of inquiry.

The second area of concern that is often stressed is privacy: This also arises from language in the Common Rule, which does not exempt—and hence raises concern about—interviews for which "disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, or reputation" (46.101 [b] [2]). In an effort to protect narrators from such potential risk or damage, IRBs frequently require that they remain anonymous; and that researchers either retain completed interviews in their possession or, preferably, destroy them after the research is completed. Yet requiring anonymity and denying accessibility violate fundamental principles of the historical discipline. Anonymous sources lack credibility in history—knowing the identities of narrators allows us to gauge their relationships to the topic at hand and hence assess the perspective from which they speak. And we typically don't hoard or destroy our evidence; we are committed to open access to sources as a way of evaluating and building upon scholarship. Moreover, while narrators can always request anonymity, they generally do not. They take pride in being identified in published scholarship, and in contributing their story to the permanent record. Preventing this violates the dignity of research subjects that IRBs are intent on preserving.

Concerns about confidentiality can generally be resolved by explaining the particular protocols of oral history to the IRB, though at times not without placing considerable burden on the researcher trying to communicate with a board uninformed about research outside the scientific paradigm. And as with the issue of psychological harm, there is the potential chilling effect.

However, a deeper disjuncture exists between the terms of the Common Rule and the terms of historical inquiry. At times information in an interview, if made public, can indeed place a person at risk of criminal or civil liability, or be damaging to his financial standing, employability, or reputation—a consideration that led one IRB administrator to tell a historian planning to study a southern community that he could not ask people about race relations because the information, if made public, might "embarrass" them.7 Yet historians' deepest responsibility is to follow the evidence where it leads, to discern and make sense of the past in all its complexity; not necessarily to protect individuals. In this we are more like journalists and unlike medical professionals, who are indeed enjoined to do no harm. Because 45 CFR 46 can be used to constrain critical inquiry, some have asserted that it contradicts the principle of academic freedom; and, insofar as 45 CFR 46 requires researchers to get permission to conduct research, some have also suggested that it violates First Amendment rights of freedom of speech and the press.8

What can be done to address these concerns?

Two years ago the AHA and the OHA secured the concurrence of the federal Office of Human Research Protections (OHRP) with a policy statement that excluded most oral history interviewing from IRB review on the grounds that it is not the kind of research covered by the federal regulations. The policy statement reads, in part, as follows:

Most oral history interviewing projects are not subject to the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46, subpart A, and can be excluded from institutional review board (IRB) oversight because they do not involve research as defined by the HHS regulations. HHS regulations at 45 CFR 46.102(D) define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The Oral History Association defines oral history as "a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life."

It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to "generalizable knowledge" that they are not subject to the requirements of the HHS regulations at 45 CFR part 46 and, therefore, can be excluded from IRB review. Although the HHS regulations do not define "generalizable knowledge," it is reasonable to assume that the term does not simply mean knowledge that lends itself to generalizations, which characterizes every form of scholarly inquiry and human communication. While historians reach for meaning that goes beyond the specific subject of their inquiry, unlike researchers in the biomedical and behavioral sciences they do not reach for generalizable principles of historical or social development, nor do they seek underlying principles or laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes. Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.

Moreover,... [a]lthough [oral history] interviews are guided by professional protocols, the way any individual interview unfolds simply cannot be predicted. An interview gives a unique perspective on the topic at hand; a series of interviews offer up not similar "generalizable" information but a variety of particular perspectives on the topic.9

However, many IRBs, which have considerable decision-making autonomy, have decided not to adhere to this policy, a decision reinforced by subsequent commentary from the OHRP suggesting that some kinds of oral history are subject to IRB review, even as it affirmed the original policy statement.10 Historians and OHRP have, in fact, been talking past each other. While the AHA and other disciplinary organizations are attempting to address the issue, what can be done in the mean time?

Some historians, it must be said, are supportive—or at least tolerant—of IRB review and willingly submit interview protocols. Others, with the concurrence of their IRB, are able to act in accordance with the "exclusion" policy. Yet others, whose IRBs do not accept oral history's exclusion, insist the regulations do not, or should not, apply to them; and have refused compliance with apparently no adverse consequence. And some, with less vigilant IRBs, simply continue to fly below the regulatory radar.

While a tenured professor might refuse or ignore compliance with impunity, this is not an advisable course for the more vulnerable members of our profession, especially graduate students, whose dissertations can—indeed have—been held up at the administrative level for failure to comply. And so departments might fruitfully take a proactive stance: informing IRBs of the principles and practices governing history in general and oral history in particular; insisting that IRBs conform to the federal requirement that they include or consult with individuals who can knowledgeably review their research, even volunteering for service on an IRB; or, as some have suggested, negotiating a departmental review of oral history research projects with some minimal reporting to the IRB.11

It would also be to everyone's advantage if departments ensured that students undertaking interviews as part of their research were trained in oral history protocols, including the necessity of securing legal releases for interviews; and were trained also in the art of interviewing.12 Especially important, in my view, is that students are provided opportunities to discuss the very real ethical issues in oral history within a framework that makes sense to historians. One of the consequences of criticizing human subjects regulations is the imputation of ethical insensitivity or arrogance. Yet there is a deep ethical narrative in oral history, one that recognizes the claims of both individual narrators and of Clio. While I remain convinced that the current regulatory system is incompatible with the work of historians, if we must live with it, we can work to make it accommodate to our terms.

Finally, keep in touch with the AHA, which is monitoring the situation and considering various actions. So is the American Association of University Professors (AAUP), whose national office has been a good ally of historians and other nonbiomedical researchers on issues of IRB review; a recent AAUP report argues that "research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption."13 If you have an active local chapter of the AAUP, you might consult with it. There is continuing debate on human subjects issues, and historians can play an important role in that debate.14

Linda Shopes first became involved in issues related to IRB review of oral history in 1997 when, as president-elect of the Oral History Association, she and other OHA representatives met with officials of the Office of Protection from Research Risks (the administrative antecedent of the Office of Human Research Protections, which oversees compliance with federal regulations governing research on human subjects), to discuss historians' concerns. Since then, as a member of the Council of the American Historical Association and as the Council representative to the Association's Research Division, she has worked to define the AHA's position on human subjects review of oral history; and, with Donald A. Ritchie representing the Oral History Association, developed the current policy statement discussed in this essay.

—Linda Shopes first became involved in issues related to IRB review of oral history in 1997 when, as president-elect of the Oral History Association, she and other OHA representatives met with officials of the Office of Protection from Research Risks (the administrative antecedent of the Office of Human Research Protections, which oversees compliance with federal regulations governing research on human subjects), to discuss historians’ concerns. Since then, as a member of the Council of the American Historical Association and as the Council representative to the Association’s Research Division, she has worked to define the AHA’s position on human subjects review of oral history; and, with Donald A. Ritchie representing the Oral History Association, developed the current policy statement discussed in this essay. Linda Shopes also sits as the external member of the Dickinson College Institutional Review Board.

Notes

1. For the full text of 45 CFR 46, go to www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm (accessed September 22, 2005). For a useful summary of the history regulations governing research on human subjects, see Constance F. Citro, Daniel R. Ilgen, and Cara B. Marrett, eds., Protecting Participants and Facilitating Social and Behavioral Research (Washington, D.C: National Academies Press, 2003), especially chapter 3, "Regulatory History;" online at www.nap.edu/books/0309088526/html (accessed September 23, 2005).

2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (Washington, D.C.: U.S. Government Printing Office, 1979); available at http://ohsr.od.nih.gov/guidelines/belmont.html (accessed September 22, 2005).

3. For a good summary of issues involved in IRB review of research in nonbiomedical fields, see "Protecting Human Beings: Institutional Review Boards and Social Science Research," Academe, 87:3 (May-June 2001), 55–67.

4. This assessment and the following discussion are based on 136 responses to the survey conducted by the American Historical Association in 2000 of campus institutional review boards.

5. "Chapter III: Basic IRB Review," Institutional Review Board Guidebook, Office of Human Research Protections, United States Department of Health and Human Services; available at http://www.hhs.gov/ohrp/irb/irb_chapter3.htm (accessed September 22, 2005).

11. The Oral History Association's guidelines for the practice of oral history are codified as Oral History Evaluation Guidelines, online at www.dickinson.edu/oha/pub_eg.html (accessed September 22, 2005); Paragraph 46.107 (a) of 45 CFR 46 states that "Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution." Elsewhere in this paragraph, it refers to IRBs as needing to [possess] the professional competence necessary to review specific research activities.

12. According to 2006 report by the Oral History Association, "Oral History and the Academy: An Assessment for the Mellon Foundation," a good many faculty and staff who conduct oral history interviews do so without adequate training; report is available at http://alpha.dickinson.edu/oha/org_bus.html.